510(k) K811165
K811165 is an FDA 510(k) premarket notification submitted by Chem-Elec, Inc. for the device "GLUCOSE OXIDASE RATE REAGENT". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Chem-Elec, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1981
- Date Received
- April 28, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type